Chenega Corporation Quality and Safety Manager 2/25-4/2026
- Established operational metrics, key performance indicators (KPIs), and continuous quality improvement processes to enhance organizational effectiveness and compliance.
- Conducted routine inspections and audits to ensure compliance with contract specifications, technical requirements, regulatory standards, and safety protocols.
- Collaborated closely with the Site Safety and Health Officer (SSHO) to align quality assurance initiatives with safety objectives and operational requirements.
- Facilitated employee training and knowledge-sharing sessions to strengthen understanding and implemented quality and safety standards.
- Facilitated and generated Post-Market Surveillance (PMS) and Periodic Safety Update Reports (PSUR) in accordance with requirements.
- Performed the root cause analysis investigations and implemented corrective and preventive actions (CAPA) to resolve identified deficiencies and improve processes.
- Conducted employee evaluations, coaching sessions in accordance with organizational policies.
- Managed, developed, and implemented continuously updated Environmental Health and Safety (EHS) policies and programs to ensure compliance with local, state, and federal regulations.
- Managed work center Hazard Communication (HazCom) programs and ensured compliance with OSHA Hazard Communication Standards.
Hasa Inc. Quality Assurance Manager 5/2024- 8/2024
- Identify business, quality, and compliance gaps and propose and implement potential improvements to systems and procedures
- Managed Quality Assurance and Quality Control (QA/QC) processes Work to maintain product quality and continuous improvement initiatives.
- Influence investigation direction, providing clear direction across all departments.
- Ensured compliance to applicable internal procedures, work to meet schedules and set timelines.
- Support teams with compiling control documents and completing of documents biweekly, follow up on action items through closure.
- Managed product containment activities to mitigate operational and safety risks through inspections and support of daily operational activities.
- Lead and support CAPA investigations, including root cause analysis, implementation of corrective/preventive actions, non-conformance reports and effectiveness checks
- Collaborated with Supplier Quality and Supply Chain teams to ensure supplier development, quality performance, and compliance with company standards.
Johnson& Johnson Snr. Quality Engineer 11/2022-6/2023
- Work with stakeholders to address audit findings in a timely manner, review audit related CAPA investigations and escalate findings as applicable.
- Manage quality, manufacturing, validation (IQ, OQ, PQ) and decommission transfer plans.
- Experience in internal audits, as well as guiding external audits.
- Plans, executes, reports and follows-up on CAPA actions, NC's and Audit Observations and conducting thorough root cause analysis.
- Support complaint handling, investigations and Post-Market Surveillance activities in regulatory.
- Work with cross-functional teams (R&D, Operations, Manufacturing, Engineering, Service and Support, Product Management, Business Development, QA, QC, Regulatory Affairs to drive resolution for internal issues and projects.
- Support Non-conformance investigations, root cause and CAPA process.
- Work with project leaders in developing and reporting appropriate performance Quality Management System metrics.
- Initiate, review and approve changes to procedures and process to ensure compliance with required standards.
- Interprets applicable regulations and standards as they apply to products, processes, practices, and procedures.
- Actively participates in Internal/External Quality System Audits (EU MDR, Intertek MDSAP, BSI, ERC, FDA, etc.)
Stryker. Snr. Quality Engineer (contract) 01/2022-11/2022
- Interface with medical device suppliers, internal development team and testing partners to ensure the quality systems are in a state of compliance and performing review and approval of quality records, design records (Investigations, impact assessments, deviations, CAPA’s), and technical development activities (CQA’’s and drawings)
- Develop protocols for gage R&R studies and gage capability studies (Cpk Studies, Capacity Studies) consistent with measurement system analysis (MSA Activities).
- Develop protocols for IQ/OQ (Equipment validation) review and approve test results for process studies.
- Managed customer complaints using SAP, managed supplier quality improvements, Implemented CAPAs after investigation.
- Ensured Quality Management System initiatives, such (SCAR, Complaints, CAPA, Non-conformance), design controls, risk management, or other areas within compliance.
- Perform statistical analysis of data to determine process capability.
- Support New Product Development activity for new purchase product, which may include: First Article Inspection.
- Investigate and drive customer complaints related to product labelling to closure in a timely manner.
- Ensured department teams transfer all deliverable to be executed and implemented at supplier site using Production Part Approval Process (PPAP).
- Develops solutions to complex problems, and/or makes significant improvements to processes, systems, or products independently to enhance performance.
- Managing validation protocols (IQ, OQ and PQ) and review of validation documents.
- Exercise considerable latitude in determining deliverables of assignments, with limited oversight for site integration to the quality systems in Stryker.
- Provides guidance, coaching and GMP training to other employees within job area.
Phillips Medical (Spectranetics) Supply Manufacturing Engineer 4/2021-12/2021
- Develop, write test methods validation in quality department.
- Lead quality improvement techniques in problem solving through troubleshooting, root cause investigations, and failure analysis of test method validation execution failures.
- Review collected data to perform statistical analysis and recommend process/product changes to improve quality.
- Participate in the development and results analysis of validation plans and test protocols to qualify and validate existing product design and process test methods. Includes the use of various statistical techniques and quality tools.
- Utilize statistical techniques to ensure robust and supportable actions to address issues or improve the system.
- Write and coordinate efforts for the development and implementation of new and updated Quality System procedures and test method procedures.
- Manage Gage R&R (Cpk Studies, Capacity Studies), validation studies, Process Validation and equipment validation studies and reports.
Abbott Vascular Quality Engineer 3/2020-4/2021
- Investigate manufacturing non-conformances for catheter (Percutaneous Heart Pump), CAPA, failure investigations and audit findings to report manufacturing related issues that may impact product quality. Proven problem-detection and problem-resolution skills.
- Support as a liaison to report on the QMS document creation, present weekly status of documents to the team and escalate issues as required.
- Managed computer management system (BMRAM) and generates required reports. Maintains respective calibration standards and test equipment.
- Resolve quality equipment, machines, and tools to correct equipment problems or process parameters that produce nonconforming products, low yields, or product quality issues.
- Interface with quality, research, and development to integrate new products or processes into the existing manufacturing area.
- Managed change management system and internal and external audits as necessary.
- Ensured CAPA subsystem (SCAR, Complaint, CAPA, Non-conformance), design controls, risk management, or other areas are within compliance Using ETQ.
- Investigate and determine root causes of quality products using quality improvement tools (Statistics, fault tree analysis, 5Whys etc.) and develop corrective action plans.
Henkel Aerospace Supply Manufacturing Engineer 1/2019-12/2019
- Investigate non-conformance and determine root cause using eight disciplines (8D’s) and A3 problem solving techniques. Ensure customer complaints resolution and develop CAPA’s.
- Managed aerospace customer complaints using SAP, managed supplier quality improvements, Implemented CAPAs after investigation.
- Managed process failure mode and effects Analysis (PFMEA) and risk assessment for all value stream teams. Review customer specifications for the aerospace.
- Conduct/Update risk analyses and track all findings, along with the development of a Risk Management portfolio, as required.
- Identified, classified, and resolved major and complex minor deviations.
- Oversee execution of remediation/CAPA activities required to continue production and/or move a process to the next milestone.
- Ensured timely closure of investigations. Led NPI projects on APQP deliverables at every gate.
- Provide quality oversight to the change management system for complex Minor and/or Major classified Change Controls. This includes verification of changes to local/multi-site SOPs and regulatory compliance and ensure communication/escalation of potential issues of broader impact to the business.
- Write product quality reports, advance change notice, quality metrics and track charts by collecting, analysing data, and summarizing information and trends.
Carl Zeiss (Contract) Manufacturing Engineer 8/2018-11/2018
- Investigate, support risk assessment, and closure of escalated complaints (critical incidents). Supported the submission of Medical Device Reports (MDR) to the FDA.
- Interface directly with suppliers to follow up on quality and performance issues; manage supplier corrective action requests.
- Document and follow up on audit results and required actions to be addressed by the supplier.
- Organize and facilitate quality trending metrics and continuous improvement activities to improve process efficiency, product compliance and control.
- Tracked, analyze, and resolved supplier performance metrics to stakeholders within quality, logistics, and manufacturing management using the appropriate software tools.
- Investigated root cause and ensured proper implementation of required corrective and preventive actions because of product complaints and audit observations, in cooperation with affected departments.
Ranin (Mettler) Oakland Manufacturing Engineer 10/2017-6/2018
- Manage supplier quality audits for new suppliers and participates in supplier approval process.
- Ensured the completion and execution of Engineering Change Orders (ECOs), Manufacturing change orders (MCO), Product/Process Change Orders.
- Disposition of nonconforming material and product management to support CAPA projects. Perform root cause analysis and take corrective action to resolve test failures.
- Solved routine technical writing and document administration following cGMP regulations and executing change control process.
- Reviewed overall document content for accuracy and proposed changes (if applicable) to assess potential impact to product safety, quality, and efficacy.
- Support and evaluate validation of equipment, tools, and methods for injection Mold qualification.
- Manage supplier audits to determine capabilities for reliable manufacture of needed raw material, including precision-machine parts, precision moulded plastic parts, plastic resins, and others
- Lead ISO 9001 internal audits as required in quality department, manufacturing, and packaging.
- Initiate Supplier Evaluations and perform Supplier Approvals
- Entered, reviewed and query data using SAP for material management, create quality notification, containment and 8D’s (CAPA’s) Using ETQ.
- Track, analyze, and resolve supplier performance metrics to stakeholders within quality, logistics, and manufacturing management using the appropriate software tools.
- Manage and provide directions including training of manufacturing personnel performing quality labelling and packaging.
Janssen (Johnson&Johnson) Validation Engineer 2/14 -8/17
- Support of Quality required Change Controls and Deviations supporting analytical methods, system validation, manufacturing processes, process/analytical equipment, and Quality Systems
- Provide support for multi-variate investigations at the site, including resolution strategies, CAPA implementation, and Material Review Board decisions.
- Executed the component tagging, Piping & Instrumentation drawings, and labelling verification test to comply with design specification.
- Maintained validated Computerized Calibration Management System (BMRAM) database, perform respective data entry, verifies data accuracy and completeness.
- Supervise the execution of cleaning validation activities on manufacturing equipment for oral dosage in manufacturing.
- Support LIMS validation and approve LIMS specification for Active pharmaceutical ingredients, Bulk drug substance and Drug products that are established to be submitted to the regulatory authorities of the quality of materials intended for clinical use.
- Manage the Installation qualification (IQ), Operational qualification (OQ), and Performance qualification (PQ) for the tablet press equipment.
- Review and approve batch production records for compliance to regulatory filling, product requirements and cGMP compliance.
- Managed EDMS/ETQ/Condor controlled document workflows in support of routine document revisions, change control, Periodic reviews, CAPA implementation, and continuous improvement as a technical writer.
- Approve product specification report for manufacturing and quality specification for clinical drug products and drug substances.
- Collaborate with cross functional partners to support generation, review, and periodic review of site Validation Plan(s) and associated validation documentation.
- Ensured the manufacture and batch disposition of clinical supplies small molecules GMP intermediates, API’s, and drug products at CMO’s is conducted in accordance with GMP.
EDUCATION: Bachelors: University Of California Berkeley.
phone: 5104795552
